(112 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: No" and the description focuses on standard image viewing and distribution functionalities. There is no mention of AI/ML algorithms, training data, or performance metrics typically associated with such technologies.
No
The device is indicated for display and rendering of medical data for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for display and rendering of medical data within healthcare institutions," and the "Device Description" section clarifies its purpose "for diagnostic purposes by trained medical professionals."
Yes
The device description explicitly states "Syngo Carbon Enterprise Access is a software only medical device".
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "display and rendering of medical data within healthcare institutions" and "clinical image and result distribution for diagnostic purposes." This focuses on the presentation and distribution of existing medical data, not on analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description emphasizes viewing and distributing various types of medical images and documents. It explicitly states it provides interfaces to medical devices "without controlling or altering their functions." This reinforces its role as a data display and distribution tool, not a device that performs diagnostic tests on samples.
- Lack of IVD Characteristics: An IVD device typically involves the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not mention any interaction with biological samples or the performance of any in vitro tests.
In summary, Syngo Carbon Enterprise Access is a software device for managing and displaying medical images and data, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.
Product codes
LLZ
Device Description
Syngo Carbon Enterprise Access is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions.
Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image object display:
• CR Image
• CT Image
• DX Image
• ES Image
• GM Image
• MG Image
• MR Image
• NM Image
• PET Image
• OP/OPT Image
• RF Image
• RT IMAGE
• SM (WSI)
• XA Image
• US Image
• Secondary capture objects
DICOM non-image object display:
• ECG
• Encapsulated PDF
• PR
Non-DICOM file display:
• Images: BMP, GIF, JPEG (JFIF), JPEG 2000, JPEG-LE, JPEG-LS, PCX, PNG, PNM, TIFF, WBMP
• Video: FLV, H.264, H.265, INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4.
VP8, VP9, WMV1, WMV2, WMV3
Text Documents: CDA (XML), PDF
Anatomical Site
No limitation concerning region of body or tissue type
Indicated Patient Age Range
No limitation concerning the patient population (e.g., age, weight, health, condition)
Intended User / Care Setting
Trained healthcare professionals / Syngo Carbon Enterprise Access is used in departmental environments within healthcare institutions. For reading images certified monitors are required (e.g., medical diagnostic displays).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device.
Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo Carbon Enterprise Access during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Performance tests were conducted to test the functionality of the device Syngo Carbon Enterprise Access. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Healthcare GmbH Vijay Ramadas Regulatory Affairs Manager Siemensstraße 3 FORCHHEIM, BAYERN 91301 GERMANY
May 23, 2024
Re: K240294
Trade/Device Name: Syngo Carbon Enterprise Access (VA40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 15, 2024 Received: April 15, 2024
Dear Vijay Ramadas:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Syngo Carbon Enterprise Access (VA40A)
Indications for Use (Describe)
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.
January 30, 2024
Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submitter:
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Establishment Registration Number: 3004977335
3. Contact Person:
Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 3 91301 Forchheim Germany
| E-mail: | vijay.ramadas@siemens-healthineers.com |
|---|---|
| Telephone: | +49 (172) 4324369 |
| Fax: | +49 (9191) 18-4404 |
4. Device Name and Classification
| Device/Trade Name: | Syngo Carbon Enterprise Access (VA40A) |
|---|---|
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Predicate Device(s):
| Device/Trade Name: | Syngo Carbon Space |
|---|---|
| 510(k) Clearance: | K230561 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
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6. Device Description:
Syngo Carbon Enterprise Access is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions.
Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.
7. Intended/Indications for use:
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.
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8. Summary of Differences between the Subject Device and the Predicate Device:
The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table:
The predicate device is available in two variants;
- Syngo Carbon Space Diagnostic Workspace ।
- Syngo Carbon Space Physician Access (web component this is the predicate for the subject device) -
For readability and comparison purpose, the non-relevant items from the predicate of Syngo Carbon Space Diagnostic Workspace) are GREYED OUT and the relevant contents are retained
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name
and version | Syngo Carbon Enterprise Access
VA40A | Syngo Carbon Space VA30A
(K230561) | New version of the
product | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications for
use | Syngo Carbon Enterprise Access is
indicated for display and rendering of
medical data within healthcare
institutions. | Syngo Carbon Space is a software
intended to display medical data and to
support the review and analysis of
medical images by trained medical
professionals.
Syngo Carbon Space "Diagnostic
Workspace" is indicated for display,
rendering, post-processing of medical
data (mostly medical images) within
healthcare institutions, for example, in
the field of Radiology, Nuclear
Medicine and Cardiology.
Syngo Carbon Space "Physician
Access" is indicated for display and
rendering of medical data within
healthcare institutions. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Contraindications | Syngo Carbon Enterprise Access is not intended for the diagnosis of digital mammography images and digital pathology reading.
Syngo Carbon Enterprise Access is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).
Syngo Carbon Enterprise Access is not intended to be used as a sole basis for clinical decisions. | Syngo Carbon Space "Diagnostic Workspace" is not intended for diagnosis of digital mammography images.
Syngo Carbon Space "Diagnostic Workspace" is not intended to be used as a sole basis for clinical decisions.
Syngo Carbon Space "Physician Access" is not intended for diagnosis of digital mammography images.
Syngo Carbon Space "Physician Access" is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).
Syngo Carbon Space "Physician Access" is not intended to be used as a sole basis for clinical decisions. | Same | NA |
| Software architecture | Syngo Carbon Enterprise Access is based on a client-server architecture | Syngo Carbon Space is based on a client-server architecture | Same | NA |
| Image communication | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. Supports interfacing with HL7 (v2.5 / v2.3.1 / v2.3 / FHIR R4) | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Image display
algorithms | MPR: MPR MIP: MIP, MinIP View AVG MED Invert Image | MPR: MPR, MPR Thick,
MPR/MPR* MIP: MIP, MIP Thin MinIP View VRT*: Plain VRT, Adapt VRT,
VRT Thin, Cinematic VRT Fused View * Invert Image * available in in Diagnostic
Workspace only | The additional AVG
and MED are non
AI/ML Algorithms | This differences
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as the
necessary measures
taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Measurement,
Evaluation/Inte
rpretation
Tools | • Distance (Distance line)
• Pixel Lens
• Angle
• Ellipse Annotation
• Polygon
• Freehand
• Capture | • Distance (Distance line, Distance
Polyline)
• Angle and Angle on stack*
• 2D ROI (Circle, Freehand,
Polygonal, Auto Contour) *
• 3D VOI (Sphere, Freehand) *
• Pixel Lens
• Ranges (Parallel, Radial, Radial
Sliced, Curved, Spine) *
• Lesion Quantification*
• Assisted Perpendicular Tool*
• Automatic Organ Segmentation*
• Interactive Tissue Segmentation*
• Time Curve, Time ROI*
• SUV Measurement*
• Automatic Anatomy Labeling
(rib, spine) *
• Next Study/Previous
Study/Nearline study*
• Change Geometry*
• Snapshot
• CT Lung Change*
• MR General Reading*
• Alpha Blending*
- Available in in Diagnostic
Workspace only | The tool set in the
subject device is
enhanced. | This differences
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as the
necessary measures
taken |
| Supported
objects
for display | DICOM image object display: | DICOM image object display: | Same | NA |
| | • CR Image | • CR Image | Same | NA |
| | • CT Image | • CT Image | | |
| | • DX Image | • DX Image | | |
| | • ES Image | • ES Image | | |
| | • GM Image | • GM Image | | |
| | • MG Image | • MG Image | | |
| | • MR Image | • MR Image | | |
| | • NM Image | • NM Image | | |
| | • PET Image | • PET Image | | |
| | • OP/OPT Image | • OP/OPT Image | | |
| | • RF Image | • RF Image | | |
| | • RT IMAGE | • RT IMAGE | | |
| | • SM (WSI) | • SM (WSI) | | |
| | • XA Image | • XA Image | | |
| | • US Image | • US Image | | |
| | • Secondary capture objects | • Secondary capture objects | | |
| | DICOM non-image object display: | DICOM non-image object display: | | |
| | • ECG | • ECG | | |
| | • Encapsulated PDF | • Encapsulated PDF | | |
| | • PR | • PR | | |
| | Non-DICOM file display: | Non-DICOM file display: | | |
| | • Images: BMP, GIF, JPEG
(JFIF), JPEG 2000, JPEG-LE,
JPEG-LS, PCX, PNG, PNM,
TIFF, WBMP | • Images: BMP, GIF, JPEG
(JFIF), JPEG 2000, JPEG-LE,
JPEG-LS, PCX, PNG, PNM,
TIFF, WBMP | | |
| | • Video: FLV, H.264, H.265,
INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4. | • Video: FLV, H.264, H.265,
INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4. | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| | VP8, VP9, WMV1, WMV2,
WMV3
Text Documents: CDA (XML), PDF | VP8, VP9, WMV1, WMV2,
WMV3
• Text Documents: CDA (XML), PDF | | |
| Operating
system | Server | Diagnostic Workspace | The operating system | This Operating
System and browser |
| | Server Red Hat Enterprise Linux 9.x Client All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: Google Chrome ≥ 90 Microsoft Edge ≥ 90 Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 15 Mobile device iPadOS ≥ 16 Apple Safari web browser >= 15 | Server Microsoft Windows Server 2019 Windows 10 Enterprise Red Hat Enterprise Linux 8.4 Client Microsoft Windows 10
(Pro, Pro-Education, Enterprise) Microsoft Windows 11
(Pro, Pro-Education,
Enterprise) Physician Access Server Red Hat Enterprise Linux 8.4 Client All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: Google Chrome ≥ 90
(tested and recommended
Chrome 100) Microsoft Edge ≥ 90
(tested and recommended:
Edge 100) Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 14 | for Linux, iOS and
Safari browser version
is updated | version difference
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Impact on Image Acquisition Devices | None
Syngo Carbon Enterprise Access is a pure viewing software and it has no influence on the image acquisition devices. | Client – Mobile device
iPadOS ≥ 14, Safari web browser
None
Syngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA |
| CAD Functionalities | None
No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | None
No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | Same | NA |
| Clinical condition the device is intended to diagnose, treat, or manage | No limitation on the clinical condition of the patient. | No limitation on the clinical condition of the patient. | Same | NA |
| Intended patient population | No limitation concerning the patient population (e.g., age, weight, health, condition) | No limitation concerning the patient population (e.g., age, weight, health, condition) | Same | NA |
| Site of the body the device is intended to be used | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Intended use
environment | Syngo Carbon Enterprise Access is
used in departmental environments
within healthcare institutions.
For reading images certified monitors
are required (e.g., medical diagnostic
displays). | Syngo Carbon Space "Diagnostic
Workspace" is used in Radiology,
Nuclear Medicine and Cardiology
environments (e.g., darkened/ shaded
rooms).
Syngo Carbon Space "Physician
Access" is used in departmental
environments within healthcare
institutions.
For reading images certified monitors
are required (e.g., medical diagnostic
displays). | Same | NA |
| Intended
user(s) | Trained healthcare professionals | Trained healthcare professionals | Same | NA |
| Device Type | Software application | Software application | Same | NA |
| Software
architecture | Syngo Carbon Enterprise Access is
based on a client-server architecture | Syngo Carbon Space is based on a
client-server architecture | Same | NA |
| Software self-
test / checks | N/A - this is a browser based
application | Client installation is prevented
automatically in case if the system
doesn't have the recommended
operating system. Also during the
launch of the client every time, the
compatibility to the server version is
checked and request to
update/upgrade to client in case of
mismatch. | NA | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Cyber Security | • User access control
• Audit Trail
• Documentation of system
security information, Network
traffic & Firewall control
• Support of virus / malware
protection
• System Hardening (OS level and
Network level) | • User access control
• Audit Trail
• Documentation of system
security information, Network
traffic & Firewall control
• Support of virus / malware
protection
• System Hardening (OS level and
Network level) | Same | NA |
| Hardware | Hardware is not understood as part of
the medical device but needs to
comply with the minimum
requirements as specified by Syngo
Carbon Enterprise Access | Hardware is not understood as part of
the medical device but needs to
comply with the minimum
requirements as specified by Syngo
Carbon Space. | Same | NA |
| Graphical user
interface | Yes, with reduced color palette,
clearer structure, and text labels on
icons. Floating panels increases the
user friendliness as the user can move
the panels wherever they are
convenient with. | Yes, with reduced color palette,
clearer structure, and text labels on
icons. Floating panels increases the
user friendliness as the user can move
| Same | NA |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| Patient
Browser | Search, browse & open data for display from syngo.share core & remote DICOM nodes Search, browse & open data for display from external XDS(-I) repository) Archive functionality (upload medical data to syngo.share core for archive) Document properties functions (metadata modification and tagging) Correct & re-arrange functions Restore (trigger fetch from archive) functions Distribution, export & sharing functions Inbox - access to medical data shared by other users | Search, browse & open data for display from syngo.share core & remote DICOM nodes Search, browse & open data for display from external XDS(-I) repository) ** Archive functionality (upload medical data to syngo.share core for archive) Document properties functions (metadata modification and tagging) Correct & re-arrange functions Restore (trigger fetch from archive) functions Distribution, export & sharing functions Inbox - access to medical data shared by other users ** *available in Physician Access only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Series
navigator /
Document
Preview | Yes, with a fast overview of the
displayed and not displayed data
(series, images) of the loaded studies,
quickly identify the relevant
series/images for reading, and bring
data (timepoints/series/images) into
display in an efficient manner
(Drag&Drop).
Study / Timepoints are marked with
individual colors for better
identification. | Yes, with a fast overview of the
displayed and not displayed data
(series, images) of the loaded studies,
identify not yet seen series/images,
quickly identify the relevant
series/images for reading, and bring
data (timepoints/series/images) into
display in an efficient manner
(Drag&Drop).
Study / Timepoints are marked with
individual colors for better
identification.
The Series Navigator is called
Document Preview for Physician
Access.
- available in in Diagnostic
Workspace only | Same | NA |
| Findings panel | Findings panel collects
measurements, annotations, and
graphical objects. Additionally, the
user can create new findings, edit
findings. It also allows creation of
automatic findings. | Findings panel collects
measurements, annotations, and
graphical objects. Additionally, the
user can create new findings, edit
findings. It also allows creation of
automatic findings. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Reporting | No dedicated report creation
functionality supported in Syngo
Carbon Enterprise Access | No dedicated report creation
functionality supported in Syngo
Carbon Space.
Structured findings can be
automatically transferred to external
third-party reporting system via FHIR
interface for creation of structured
report content [e.g. (Powerscribe [by
Nuance], SmartReports [by Smart
Reporting)] | Same | NA |
| Image
Archiving | Not applicable since Syngo Carbon
Enterprise Access does not create data
or images that is transferred/stored. | Diagnostic Workspace:
Syngo Carbon Space Diagnostic
Workspace does not store data or
images.
Created results for a study (e.g.
DICOM PR, SR objects) are stored in
syngo.share core in context of the
original study. syngo.share core is
responsible for long term archiving of
the original study and created results.
Physician Access:
Not applicable since Syngo Carbon
Space Physician Access does not
create data or images that is
transferred/stored | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Patient Jacket | Provides access to patient history –
other studies of patient stored in
remote DICOM nodes. Also provides
a study content preview along with
access to nearline studies and prior
RIS reports | Provides access to patient history –
other studies of patient stored in
syngo.share core or
remote DICOM nodes. Also provides
| Same | NA |
| Optimization &
preparation/
Spatial
Operation tools | Image Preview Zoom/Pan Synch, Align Windowing Flip (Horizontal, Vertical) Blow-up Scroll Movie Magnifier | Image Preview Zoom/Pan Fit to Segment*, Fit to
Acquisition Size* Synch, Align Windowing Rotate (2D image or 3D
Volume*) Flip (Horizontal, Vertical) Shutters On/Off* Blow-up Scroll Movie Clipping* Punching and Masking* Magnifier * available in in Diagnostic
Workspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Annotation
Tool | • Text | • Arrow*
• Marker*
• Text
- available in in Diagnostic
Workspace only | Same | NA |
| Printing | Provides printing functionality on a
paper printer. | Diagnostic workspace:
Provides printing functionality with
able to review, modify the images
along with selecting the print sheet
format exposing then the DICOM
printer.
Also, able to monitor the printing
status and retry a printing task, if
needed.
Note
• DICOM printer must be configured as DICOM
nodes
• Grayscale & color printing is supported
Physician Access:
Provides printing functionality on a
paper printer. | Same | NA |
| Online help
system | Yes, with search, indexing, filtering,
library function and document
collections. | Yes, with search, indexing, filtering,
library function and document
collections. | Same | NA |
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9. Clinical Testing
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device
10. Non-clinical Performance Testing:
Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- ISO 14971 Third Edition 2019-12 -
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
- IEC 82304-1 Edition 1.0 2016-10 -
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION -
11. Software Verification and Validation:
Basic documentation as per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo Carbon Enterprise Access during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Enterprise Access.
12. Summary:
Performance tests were conducted to test the functionality of the device Syngo Carbon Enterprise Access. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
13. Safety and Effectiveness Information:
Software specifications, descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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14. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.
In summary, we are of the opinion that the subject device Syngo Carbon Enterprise Access, software version VA40A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device Syngo Carbon Space VA30A.